MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.0MM IMF SCREW SELF-DRILLING 12MM; SCREW FIXATION INTRAOSSEOUS

Catalog Number 201.932S

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Lot number is either l817379 with manufacture date of 3/15/2018 and expiration date of 3/1/2028 or l736853 with manufacture date of 1/18/2018 and expiration date of 1/1/2028.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on an unknown date a midface inter maxillary fixation (imf) screw was found broken.Surgery was delayed approximately 1 hour.This report is for one (1) 2.0mm imf screw.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative.Additional corrected data: lot#.Device evaluated by mfr, device manufacture date.Device history lot.Please note, this dhr review is for sterilization procedure only: part no: 201.932s, lot no: l736853, manufacturing location: selzach, supplier: frueh ag, release to warehouse date: 18.Jan.2018, expiry date: 01.Jan.2028, non-sterile 201.932 / l720616 was manufactured in mezzovico, release to warehouse date: 04.Jan.2018.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Please note, this dhr review is for sterilization procedure only: part no: 201.932s, lot no: l817379, manufacturing location: selzach, supplier: frueh ag, release to warehouse date: 15.Mar.2018, expiry date: 01.Mar.2028, non-sterile 201.932 / l792176 was manufactured in mezzovico, release to warehouse date: 27.Feb.2018.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Please note, this dhr review is for sterilization procedure only: part: 201.932s; lot: l736853; manufacturing location: selzach; supplier: frueh ag; release to warehouse date: january 18, 2018; expiry date: january 01, 2028 non-sterile 201.932 / l720616 was manufactured in mezzovico.Release to warehouse date: january 04, 2018 the device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.The raw material certificate 17662 was reviewed and the used material was according to iso-5832-1 specification for implants for surgery.Please note, this dhr review is for sterilization procedure only: part: 201.932s; lot: l817379; manufacturing location: selzach; supplier: frueh ag; release to warehouse date: march 15, 2018; expiry date: march 01, 2028 non-sterile 201.932 / l792176 was manufactured in mezzovico.Release to warehouse date: february 27, 2018 the device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.The raw material certificate 17662 was reviewed and the used material was according to iso-5832-1 specification for implants for surgery.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Product was not returned, therefore no further investigation is possible.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.0MM IMF SCREW SELF-DRILLING 12MM
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7998003
• MDR Text Key: 124816836
• Report Number: 8030965-2018-57561
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 07611819747807
• UDI-Public: (01)07611819747807
• Combination Product (y/n): N
• PMA/PMN Number: K010527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201.932S
• Device Lot Number: L736853
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2018
• Initial Date FDA Received: 10/23/2018
• Supplement Dates Manufacturer Received: 11/15/2018; 11/15/2018; 12/30/2018
• Supplement Dates FDA Received: 11/15/2018; 11/15/2018; 12/31/2018
• Patient Sequence Number: 1